• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker) AccuPlace Round Level Needle Guide

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Stryker) AccuPlace Round Level Needle Guidesee related information
Date Initiated by FirmFebruary 04, 2016
Date PostedMarch 03, 2016
Recall Status1 Terminated 3 on May 09, 2017
Recall NumberZ-1038-2016
Recall Event ID 73172
510(K)NumberK904172 
Product Classification Guide, needle, surgical - Product Code GDF
Product(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Code Information Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003. Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactKara Spath
800-253-4518
Manufacturer Reason
for Recall
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
FDA Determined
Cause 2
Package design/selection
ActionStryker sent URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to Customers via Overnight service. Stryker Sales Representatives were notified via email. 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many AccuPlace" Needle Guides are at your facility. Discontinue use of the AccuPlace" Needle Guides. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to kara.spath@stryker.com. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. In addition, Stryker Instruments sent recall notifications directly to facilities that received recalled product(s) originally shipped by Inrad. Facilities that received products from both Stryker and Inrad will receive one recall notification. The Business Reply Form will be pre-filled to indicate specifically what recalled products were sent to each facility, including the quantity and Product Number(s).
Quantity in Commerce5,800 units total
DistributionNationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GDF
-
-